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# iCAD PMA Approved for Breast Imaging Aid
- URL: https://www.fdaweb.com/icad-pma-approved-for-breast-imaging-aid/
- Published: 2017-03-27T12:00:00.000Z
- Updated: 2026-09-14T22:14:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138298

FDA has approved an iCAD PMA for its PowerLook Tomo Detection device, a concurrent-read computer aided detection product for digital breast 3D tomosynthesis. “PowerLook Tomo Detection improves radiologists’ efficiency by automatically analyzing each tomosynthesis plane and identifying suspicious areas,” the company says. “The suspicious areas are naturally blended onto a 2D synthetic image to provide radiologists with a single enhanced image that is used to more efficiently navigate the large tomosynthesis data set.”

  
Approval was based on data from a U.S. clinical study that showed radiologists were able to significantly reduce reading time when reading 3D tomosynthesis exams with PowerLook, according to the company. The study included 20 radiologists reading 240 tomosynthesis cases both with and without the PowerLook Tomo Detection technology. Reading time was reduced by up to 37% with an average reduction of 29% when using the device, it says.